Aerin Medical, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Aerin Medical, Inc.” (first 2015, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 94 days. Since 2017 the median was 94 days, against 116 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 253 |
| 2016 | 1 | 65 |
| 2017 | 2 | 102 |
| 2018 | 0 | — |
| 2019 | 1 | 101 |
| 2020 | 1 | 67 |
| 2021 | 0 | — |
| 2022 | 1 | 29 |
| 2023 | 0 | — |
| 2024 | 2 | 74 |
| 2025 | 0 | — |
| 2026 | 1 | 90 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Aerin Medical, Inc. took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 9 | 9 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 | 1 |
Review panels
Most recent Aerin Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260522 | RhinAer+ Stylus | GEI | 2026-05-18 | 90 |
| K242630 | Aerin Console | GEI | 2024-12-10 | 98 |
| K240253 | Reach Needle | BSP | 2024-03-21 | 51 |
| K221907 | RhinAer® Stylus (FG1393) | GEI | 2022-07-29 | 29 |
| K200300 | VivAer Stylus | GEI | 2020-04-13 | 67 |
| K192471 | RHIN1 Stylus | GEI | 2019-12-20 | 101 |
| K172529 | Vivaer ARC Stylus | GEI | 2017-12-05 | 106 |
| K162810 | InSeca ARC Stylus, Aerin Console | GEI | 2017-01-11 | 97 |
| K161994 | Aerin Medical Stylus | GEI | 2016-09-22 | 65 |
| K150637 | Aerin Medical Wand Model FG011 | GEI | 2015-11-19 | 253 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2024-11-12.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Aerin Medical, Inc. is the lead sponsor of 13 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06922955: A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction. (Active not recruiting, started 2025-02-28)
- NCT06599736: A Study of RhinAer Stylus for Treating Chronic Rhinitis (Active not recruiting, started 2024-10-03)
- NCT05099263: The Vivaer Procedure for Treatment of the Septal Swell Bodies (SWELL) (Completed, started 2021-09-14)
- NCT04684875: Quality of Life Impact of Chronic Rhinitis Treatment With Aerin Medical Device (Completed, started 2020-11-19)
- NCT04614324: A Study of RhinAer ARC Stylus for Treating Chronic Rhinitis (RELIEF) (Completed, started 2020-10-05)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aerin Medical, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Aerin Medical, Inc.” (first 2015, latest 2026), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Aerin Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aerin Medical, Inc. is 94 days. Since 2017: 94 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Aerin Medical, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 9); BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 1).
Next steps
- See all 10 Aerin Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Aerin Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.